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NCT05464420 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,162
- Enrollment target
NCT05464420: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT05464420 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 2,162 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (180% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05464420, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,162 participants
- Enrollment target
Study Summary
This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.
Primary Outcome
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included pain/tenderness, redness/erythema, and swelling. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Interventions
- BIOLOGICAL V116
- BIOLOGICAL PPSV23
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,162 participants |
| Start Date | 2022-08-12 |
| Est. Completion | 2023-05-25 |
| Phase | Phase 3 |
What the finished NCT05464420 record still lists
NCT05464420 is an interventional study that assigns participants to a tested intervention. Its 2,162 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (180% higher).
The record links to 0 conditions, and to 2 interventions - of which V116 is the first listed.
NCT05464420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05464420 about?
NCT05464420 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)". This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonoph...
What is the current status of trial NCT05464420?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,162 participants. The study started on 2022-08-12. Estimated completion is 2023-05-25.
What interventions are being tested in trial NCT05464420?
The interventions under investigation include: V116 (BIOLOGICAL), PPSV23 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05464420?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05464420's enrollment target sits among peer trials
2,162 95th of 2000 higher than 1,906 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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